# K034050: Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220F

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corporation
- Decided: Mar 22, 2004 after 83 days
- Product code: DTK (Filter, Intravascular, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.3375
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K901502 (1990). 22 ancestors in all.
5 later devices descend from it; 3 cite it directly.
4 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023116: Cordis Optease Permanent Vena Cava Filter, Models 466-F200A, 466-F200B, Cordis Corp. (2002) Summary page 1.
- K000062: Cordis Trapease Permanent Vena Cava Filter and Introduction Kit, Cordis Corp. (2000) Summary page 1.
- K020316: Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator; Models 466-P306AU & 466-P306BU, Cordis Corp. (2002) Summary page 1.
- K031328: Recovery Filter System, Model RF-048F, C.R. Bard, Inc. (2003) Summary page 1.
- K032426: Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set, Cook, Inc. (2003) Summary page 1.
- K965211: Vista Brite Tip Catheters, Cordis Corp. (1997) Summary page 1.

## Most influential descendants
- K162875: Sentry IVC filter (2017), 2 descendants of its own
- K173236: Sentry IVC Filter (2018), 1 descendant of its own
- K091077: Optease Vena Cava Filter and Retrieval Catheter (2010), 1 descendant of its own
- K181202: Sentry IVC Filter (2018), 0 descendants of its own
- K140286: Optease Vena Cava Filter and Optease Retrieval Cathteter (2014), 0 descendants of its own

## Recalls of this device
- Mar 29, 2013 · Class I · Z-1887-2013: Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.

## Indications for use
The OPTEASE Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: · Pulmonary thromboembolism when anticoagulants are contraindicated, · Failure of anticoagulant therapy for thromboembolic disease, * Emergency treatment following massive pulmonary embolism where anticipated, * Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated The OPTEASE Filter may be retrieved according to the instructions supplied in the Section labeled: Optional Procedure for Filter Retrieval. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the vena cava.

Source page: https://510kreport.com/device/K034050
Methodology: https://510kreport.com/methodology